PIT — Leishmania Spp. Antigen Detection Assay Class I
FDA product code PIT covers "Leishmania Spp. Antigen Detection Assay", a Class I medical device regulated under 21 CFR 866.3870. Submissions are reviewed by the Microbiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- PIT
- Device Class
- Class I
- Regulation Number
- 866.3870
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
An in vitro diagnostic test for the detection of Leishmania spp. antigens to aid in the diagnosis of Leishmania spp. infection.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K141341 | inbios international | CL DETECT RAPID TEST | November 14, 2014 |